Respiratory Distress Syndrome
Conditions
Keywords
RDS, Infant, newborn, NIPPV, CPAP
Brief summary
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
Detailed description
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate standard therapy. Nevertheless, NIPPV has never been used in chinese babies. The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
Interventions
DEVICENIPPV
Ventilator is Bird VIP.
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 28 Days
Healthy volunteers
No
Inclusion criteria
1. Newborn infants with birth weight \>500 gm. 2. Gestational age \>24 completed weeks. 3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support. 4. No known lethal congenital anomaly or genetic syndromes. 5. Signed parental informed consent.
Exclusion criteria
1. Considered non-viable by clinician (decision not to administer effective therapies) 2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis) 3. Infants known to require surgical treatment 4. Abnormalities of the upper and lower airways 5. Neuromuscular disorders 6. Infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. | At 7 days after non-invasive respiratorynsupport. |
Secondary
| Measure | Time frame |
|---|---|
| Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age. | At 7 days, 28 days and at 36 weeks postmenstraul age |
Countries
China
Outcome results
None listed